ES2679819T3 - Composición, método y kit para inhibidor de alfa-1 proteinasa - Google Patents

Composición, método y kit para inhibidor de alfa-1 proteinasa Download PDF

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Publication number
ES2679819T3
ES2679819T3 ES10828979.4T ES10828979T ES2679819T3 ES 2679819 T3 ES2679819 T3 ES 2679819T3 ES 10828979 T ES10828979 T ES 10828979T ES 2679819 T3 ES2679819 T3 ES 2679819T3
Authority
ES
Spain
Prior art keywords
api
composition
amino acid
alanine
formulation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
ES10828979.4T
Other languages
English (en)
Spanish (es)
Other versions
ES2679819T8 (es
Inventor
Jianxin Guo
Anthony Klos
Bret Coldren
Deborah Barnette
Mark Manning
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Grifols Therapeutics LLC
Original Assignee
Grifols Therapeutics LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=43970713&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2679819(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Grifols Therapeutics LLC filed Critical Grifols Therapeutics LLC
Application granted granted Critical
Publication of ES2679819T3 publication Critical patent/ES2679819T3/es
Publication of ES2679819T8 publication Critical patent/ES2679819T8/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Zoology (AREA)
  • Inorganic Chemistry (AREA)
  • Pulmonology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Cosmetics (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
ES10828979.4T 2009-11-03 2010-11-02 Composición, método y kit para inhibidor de alfa-1 proteinasa Active ES2679819T3 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US25771109P 2009-11-03 2009-11-03
US257711P 2009-11-03
PCT/US2010/055135 WO2011056793A2 (en) 2009-11-03 2010-11-02 Composition, method, and kit for alpha-1 proteinase inhibitor

Publications (2)

Publication Number Publication Date
ES2679819T3 true ES2679819T3 (es) 2018-08-31
ES2679819T8 ES2679819T8 (es) 2019-01-22

Family

ID=43970713

Family Applications (1)

Application Number Title Priority Date Filing Date
ES10828979.4T Active ES2679819T3 (es) 2009-11-03 2010-11-02 Composición, método y kit para inhibidor de alfa-1 proteinasa

Country Status (19)

Country Link
US (2) US20130131192A1 (enExample)
EP (1) EP2496246B1 (enExample)
JP (2) JP2013510158A (enExample)
KR (1) KR20120114235A (enExample)
CN (1) CN102655876B (enExample)
AU (1) AU2010315325B2 (enExample)
BR (1) BR112012010392B8 (enExample)
CA (1) CA2779369C (enExample)
CL (1) CL2012001159A1 (enExample)
ES (1) ES2679819T3 (enExample)
HU (1) HUE039240T2 (enExample)
IL (1) IL219485A (enExample)
MX (1) MX2012005132A (enExample)
NZ (1) NZ599783A (enExample)
PL (1) PL2496246T3 (enExample)
PT (1) PT2496246T (enExample)
RU (1) RU2555332C2 (enExample)
TR (1) TR201809898T4 (enExample)
WO (1) WO2011056793A2 (enExample)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2012337241B2 (en) * 2011-12-30 2016-10-13 Grifols, S.A. Alpha1-proteinase inhibitor for delaying the onset or progression of pulmonary exacerbations
US20210085764A1 (en) * 2016-12-22 2021-03-25 Kamada Ltd. Dry powder formulations of alpha-1 antitrypsin
WO2018132874A1 (en) * 2017-01-19 2018-07-26 Csl Limited Method of preventing an immune response with alpha- 1 anti-trypsin
IL267923B2 (en) 2018-08-02 2023-06-01 Grifols Worldwide Operations Ltd The composition containing the most concentrated alpha-1 type protein inhibitor and a method for obtaining it
JP7545987B2 (ja) 2019-03-04 2024-09-05 ティーエーイー ライフ サイエンシーズ ホウ素中性子捕捉療法において使用するためのボリル化されたアミノ酸組成物およびその方法
BR112022016234A2 (pt) 2020-02-25 2022-10-11 Grifols Worldwide Operations Ltd Método para obtenção de inibidor de proteinase alfa-1

Family Cites Families (45)

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JPS5029005B2 (enExample) * 1972-05-08 1975-09-19
JPS51118819A (en) * 1975-04-08 1976-10-19 Green Cross Corp:The A process for preparing heat stable antitrypsin
JPS597693B2 (ja) 1978-01-07 1984-02-20 株式会社ミドリ十字 抗トロンビン製剤及びその製法
US4337242A (en) 1980-02-05 1982-06-29 Merck & Co., Inc. Vaccine stabilizer containing L-glutamic acid and L-arginine
US4623717A (en) * 1980-03-05 1986-11-18 Miles Laboratories, Inc. Pasteurized therapeutically active protein compositions
EP0082481B2 (en) 1981-12-23 1990-09-12 Schering Corporation Stabilised alpha-interferon formulations and their preparation
US4517294A (en) 1982-03-03 1985-05-14 Genentech, Inc. Human antithrombin III
US4632981A (en) 1982-07-30 1986-12-30 Genentech, Inc. Human antithrombin III
US5218091A (en) 1982-08-13 1993-06-08 Zymogenetics, Inc. Glycolytic promoters for regulated protein expression: protease inhibitor
US4711848A (en) 1984-03-14 1987-12-08 Zymogenetics, Inc. Site specific mutagenesis in alpha-1-antitrypsin
US4931373A (en) 1984-05-25 1990-06-05 Zymogenetics, Inc. Stable DNA constructs for expression of α-1 antitrypsin
US4732973A (en) 1984-06-14 1988-03-22 Chiron Corporation Active site modified protease α-1-antitrypsin inhibitors
JP2599585B2 (ja) 1984-06-19 1997-04-09 トランスジ−ン ソシエテ アノニム ヒトα▲下1▼−アンチトリプシン誘導体及びその製造法
US5322775A (en) 1986-06-30 1994-06-21 Pharmaceutical Proteins Ltd. Peptide production
US4873316A (en) 1987-06-23 1989-10-10 Biogen, Inc. Isolation of exogenous recombinant proteins from the milk of transgenic mammals
DE3901917A1 (de) 1989-01-24 1990-07-26 Behringwerke Ag Mutanten von humanem antithrombin iii
GB8913183D0 (en) 1989-06-08 1989-07-26 Central Blood Lab Authority Chemical products
US5079336A (en) 1989-06-23 1992-01-07 The Trustees Of The University Of Pennsylvania α-1-antichymotrypsin, analogues and methods of production
US5032405A (en) 1989-09-27 1991-07-16 Warner-Lambert Company Oral pharmaceutical composition for acid sensitive proteinaceous agents
US5134119A (en) 1990-10-16 1992-07-28 Lezdey John Treatment of inflammation using 358 substituted alpha-antitrypsin
JP3479539B2 (ja) 1992-04-10 2003-12-15 エーザイ株式会社 ヒトアンチトロンビンiii変異体
US6051256A (en) * 1994-03-07 2000-04-18 Inhale Therapeutic Systems Dispersible macromolecule compositions and methods for their preparation and use
FR2719479B1 (fr) * 1994-05-04 1996-07-26 Sanofi Elf Formulation stable lyophilisée comprenant une protéine: kit de dosage.
US5561115A (en) 1994-08-10 1996-10-01 Bayer Corporation Low temperature albumin fractionation using sodium caprylate as a partitioning agent
US5843705A (en) 1995-02-21 1998-12-01 Genzyme Transgenic Corporation Transgenically produced antithrombin III
AT407114B (de) 1997-06-10 2000-12-27 Immuno Ag Alpha 1-antitrypsin-präparation sowie verfahren zu deren herstellung
IL139531A0 (en) 1998-05-12 2001-11-25 Human antithrombin iii, methods for the production thereof and pharmaceutical compositions containing the same
CZ307715B6 (cs) 1999-02-22 2019-03-06 University Of Connecticut Způsob lyofilizace vodné farmaceutické formulace faktoru VIII prosté albuminu
WO2000051624A2 (en) * 1999-03-05 2000-09-08 The Trustees Of University Technology Corporation Methods and compositions useful in inhibiting apoptosis
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BRPI0707634A2 (pt) 2006-02-09 2011-05-10 Kamada Ltd alfa-1 antitripsina para tratar episàdios de exacerbaÇço de doenÇas pulmonares
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Also Published As

Publication number Publication date
RU2555332C2 (ru) 2015-07-10
PL2496246T3 (pl) 2018-09-28
JP6030201B2 (ja) 2016-11-24
WO2011056793A3 (en) 2011-09-29
AU2010315325B2 (en) 2014-11-27
US20160106843A1 (en) 2016-04-21
JP2013510158A (ja) 2013-03-21
EP2496246B1 (en) 2018-06-27
KR20120114235A (ko) 2012-10-16
BR112012010392B1 (pt) 2021-01-05
NZ599783A (en) 2013-10-25
CA2779369C (en) 2018-06-19
US20130131192A1 (en) 2013-05-23
AU2010315325A1 (en) 2012-06-07
ES2679819T8 (es) 2019-01-22
US9616126B2 (en) 2017-04-11
PT2496246T (pt) 2018-07-31
IL219485A (en) 2017-06-29
RU2012122793A (ru) 2013-12-10
TR201809898T4 (tr) 2018-07-23
JP2015221835A (ja) 2015-12-10
CL2012001159A1 (es) 2012-09-14
CN102655876A (zh) 2012-09-05
HUE039240T2 (hu) 2018-12-28
MX2012005132A (es) 2012-07-25
BR112012010392A2 (pt) 2016-07-12
CA2779369A1 (en) 2011-05-12
EP2496246A2 (en) 2012-09-12
WO2011056793A2 (en) 2011-05-12
BR112012010392B8 (pt) 2021-05-25
IL219485A0 (en) 2012-06-28
EP2496246A4 (en) 2013-03-27
CN102655876B (zh) 2015-07-15

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